A Pilot Study Evaluating the Potential of 18F Fluorodeoxyglucose PET-CT Imaging in Diagnosing Cardiac Rejection.

NCT06519240 | Not Yet Recruiting

• 1 other identifier: 335590/1660859/37/429
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot study aims to assess whether 18F-FDG PET CT imaging has the potential in diagnosing cardiac rejection. The investigators aim to recruit 20 heart transplant subjects within two groups of 10 subjects each. One group will have participants with definite rejection and the other group will have participants with definite no rejection. Subjects will be placed into study groups based on their heart muscle biopsy, echocardiogram, clinical symptoms, ECG, and presence or absence of donor specific antibodies. Each group will then undertake a 18F-FDG PET CT scan to identify whether this imaging modality has a role in identifying cardiac rejection. The study subjects and the research team will be blinded to the results of the PET CT until the end of the study.

Conditions

Cardiac Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• Define the sensitivity and specificity of FDG PET CT in the diagnosis of cardiac rejection, when compared to the current clinical standard (cardiac biopsy and Echocardiography)

  We aim to confirm the sensitivity and specificity of FDG PET CT in diagnosing cardiac rejection

  18 months

Secondary Outcomes (1)

• Practicality and acceptability of FDG PET CT imaging to patients

  18 months

Study Arms (2)

Patients with a diagnosis of cardiac rejection

ACTIVE COMPARATOR

Based on heart muscle biopsy findings. Subjects must have no significant coronary disease within the last 12 months (with a confirmatory angiogram, computed tomography coronary angiogram, myocardial perfusion scan, cardiac magnetic resonance imagining, or other coronary ischaemia test.

Radiation: 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)

Patients with no evidence of cardiac rejection

ACTIVE COMPARATOR

Based on heart muscle biopsy findings

Radiation: 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)

Interventions

18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT) RADIATION

Each participant will prepare for their study PET CT by following an initial 18 hour of zero carbohydrate diet followed by another 18 hours of fasting (water allowed). After confirming preparation, each study participant will have a single rest rubidium and 18F-FDG PET CT scan.

Patients with a diagnosis of cardiac rejection; Patients with no evidence of cardiac rejection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All heart transplant recipients with definite cardiac rejection or definite no rejection with evidence of no significant coronary disease within the last 12 months (e.g with any of the following tests (1)angiogram (2) CTCA (3) MPS (4) CMR (5) other coronary ischaemia test)

You may not qualify if:

• Unable to have a PET CT scan or comply with the dietary protocol
• Age less than 18 years old
• Unable to consent
• Presence of significant coronary disease or coronary ischaemia
• Insulin dependent diabetics
• Pregnant or breast feeding individuals

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Related Publications (1)

• Daly KP, Dearling JL, Seto T, Dunning P, Fahey F, Packard AB, Briscoe DM. Use of [18F]FDG Positron Emission Tomography to Monitor the Development of Cardiac Allograft Rejection. Transplantation. 2015 Sep;99(9):e132-9. doi: 10.1097/TP.0000000000000618.

  PMID: 25675207 RESULT

Study Officials

• Mansimran Dulay, MBBS MRCP

  Royal Brompton and Harefield Hospital

  STUDY DIRECTOR

Central Study Contacts

Owais Dar, MRCP MD(Res)

CONTACT

+44(0)1895828898; o.dar@rbht.nhs.uk

Ramey Assaf, MBBS BMedSci

CONTACT

+44(0)1895828898; r.assaf@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: July 25, 2024
• Study Start: September 30, 2024
• Primary Completion: October 2, 2025
• Study Completion (Estimated): October 2, 2026
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share